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Details

As part of a move towards an increase in self-regulation of medicines labelling and patient information, this guidance has been developed to help those responsible for the design and content of patient information leaflets.

It sets out the legal framework for patient information leaflets as described in EU and national legislation and it describes best practice for information design to ensure that patients who rely on the information provided can make informed decisions about the safe and effective use of the medicines they take.

This document is guidance and is not a legal interpretation of national and EU regulations.

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